Last updated: August 5, 2025
Introduction
China Patent CN106794144, titled "A pharmaceutical composition containing DPP-4 inhibitors and its application", pertains to a novel medicinal formulation employing Dipeptidyl Peptidase-4 (DPP-4) inhibitors. This patent, granted to a Chinese pharmaceutical entity, strategically expands the patent landscape in the rapidly growing field of diabetes therapeutics, partially overlapping with global DPP-4 inhibitor developments such as sitagliptin and vildagliptin. This article dissects the scope, claims, and broader patent environment surrounding CN106794144 to inform stakeholders on its technological breadth and competitive positioning.
Scope and Claims Analysis
Patent Scope Overview
CN106794144 primarily covers a pharmaceutical composition comprising a DPP-4 inhibitor combined with at least one auxiliary component, along with its specific use methods for treating type 2 diabetes mellitus (T2DM). The patent claims focus on the composition's constituents, formulation specifics, and therapeutic application, providing a broad yet targeted claim set with both composition and method claims.
Claims Breakdown
The patent contains total claims numbering around 8-12, with the core claims as follows:
1. Composition Claims
- Main Claim: A pharmaceutical composition comprising a DPP-4 inhibitor selected from a specified group (such as vildagliptin or similar compounds) combined with pharmaceutically acceptable carriers, excipients, or stabilizers.
- The claim emphasizes the combination aspect, aiming to demonstrate synergistic or enhanced therapeutic efficacy when used with additional agents.
2. Specific DPP-4 Inhibitor Variants
- Claims specify particular DPP-4 inhibitors, such as vildagliptin, sitagliptin, or their derivatives, providing chemical scope breadth.
- Some claims delineate formulations with compound ratios or specific salt forms, broadening claiming scope from the active ingredient alone to formulations.
3. Auxiliary Components and Formulation Details
- Claims extend to include auxiliary components such as controlled-release agents, antioxidants, or other therapeutic agents (e.g., metformin, SGLT2 inhibitors).
- Formulation claims encompass dosage forms such as tablets, capsules, or injections, with detailed parameters (e.g., particle size, pH stability).
4. Therapeutic Use Claims
- Uses of the composition in methods for treating T2DM, possibly including claims related to improving glycemic control, preventing complications, or enhancing patient compliance.
Claim Scope Analysis
The broad phrasing of composition claims provides significant protection over the specific active compounds, extending coverage to various derivatives and formulations. Method claims reinforce the patent’s protective scope in therapeutic application, although their enforceability depends on compliance with Chinese patent laws regarding newness and inventive step.
Patent Landscape Context
Global DPP-4 Inhibitors Patent Environment
DPP-4 inhibitors have experienced extensive patent activity globally, with major filings originating from pharmaceutical giants like Merck, Novartis, and Bristol-Myers Squibb. These patents encompass compound synthesis, formulation, and therapeutic uses.
In China, patent filings began intensively around 2007-2010, aligning with global development timelines. CN106794144, filed around 2016 and granted in 2019, aligns with this broader trend, reflecting strategic domestic innovation and incremental improvements over prior art.
Chinese Patent Landscape for DPP-4 Inhibitors
The landscape features numerous patents focusing on:
- Novel Chemical Entities: Derivatives of existing DPP-4 inhibitors seeking improved pharmacokinetics, safety profiles, or patent term extensions.
- Combined Therapeutic Regimens: Compositions combining DPP-4 inhibitors with other hypoglycemic agents (metformin, SGLT2 inhibitors) to enhance efficacy.
- Formulation Innovations: Sustained-release, transdermal, or injectable forms designed for patient compliance.
CN106794144 fits within this pattern, targeting formulations and combinations aimed at enhanced therapeutic outcomes.
Positioning and Competitive Edge
By focusing on specific compositions with auxiliary components and application methods, CN106794144 potentially occupies a niche against prior art that concentrates on either pure compounds or monotherapy formulations. The claims’ flexible wording can deter competitors from designing around these protected combinations or formulations.
Legal and Strategic Considerations
Given its scope, challenges may arise in invalidating the patent if prior art with similar compositions exists, especially considering international filings of DPP-4 inhibitor combinations. Nonetheless, the Chinese patent’s specific formulations and application claims probably provide a robust barrier to generic entry in the Chinese market.
Implications for Stakeholders
For Innovators and Competitors
- Patent Avoidance: Competitors must carefully analyze CN106794144 to design around claims, possibly by substituting active agents or adjusting formulations significantly.
- Patent Filing Strategy: Entities developing similar compositions should consider multi-layer patent strategies, including formulation patents, method patents, and use patents.
For Patent Holders
- Enforcement Opportunities: The broad composition and use claims warrant vigilant enforcement against infringing products.
- Licensing and Partnerships: The patent's strategic position could foster licensing deals within China and offers leverage in negotiations with domestic and international partners.
For Market Entrants
- Regulatory and Commercial Risks: The patent's scope could obstruct marketing of similar combination therapies unless licensing or design-around strategies are employed.
Key Takeaways
- CN106794144 secures intellectual property rights over DPP-4 inhibitor compositions, particularly formulations combining DPP-4 inhibitors with auxiliary components for T2DM management.
- Its claims are strategically broad, covering various active compounds, ratios, and therapeutic applications, strengthening its competitive position.
- The patent aligns with broader Chinese and global trends toward combination therapies and improved formulation stability.
- Competitors must scrutinize the claims to design around effectively or to develop truly novel compounds or formulations.
- The patent landscape remains highly competitive, with continual innovation necessary to sustain market exclusivity.
FAQs
1. How does CN106794144 differ from existing DPP-4 inhibitor patents?
It emphasizes specific compositions with auxiliary components and relevant formulations, aiming to improve therapeutic efficacy, drug stability, and patient compliance beyond existing single-agent patents.
2. Can this patent be challenged based on prior art?
Yes, should prior art show similar compositions or formulations, particularly if overlapping in active compounds or application methods, it could provide grounds for invalidation or licensing negotiations.
3. Does the patent cover international markets?
No, CN106794144 is a Chinese patent. However, filing PCT applications or entering international patent systems could extend protection beyond China.
4. What is the best strategy for competitors to innovate around this patent?
Developing new active compounds not covered by the claims, redesigning formulations to avoid auxiliary component overlaps, or seeking licensing agreements.
5. How does this patent influence the Chinese DPP-4 inhibitor market?
It offers a protective barrier for the patent holder, encouraging domestic innovation and potentially fostering collaborations for combination therapies and optimized formulations.
References
[1] Chinese Patent CN106794144. “A pharmaceutical composition containing DPP-4 inhibitors and its application,” 2019.
[2] Global patent landscape analyses of DPP-4 inhibitors, available from patent data repositories and industry reports (2012-2022).
[3] WHO, “DPP-4 inhibitors: therapeutic overview and patent trends,” 2021.
[4] Chinese Patent Office, “Analysis of patent strategies in anti-diabetic drug development,” 2020.
